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Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
placement of fissure sealant
fluoride varnish
silver fluoride
placebo control
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring tooth decay, fluoride, sealant, prevention

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • school children in good general health
  • have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries

Exclusion Criteria:

  • children with major systemic disease or taking long-term medications
  • not cooperative or refuse dental treatments

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

fissure sealant

fluoride varnish

SDF solution

control

Arm Description

single placement of resin fissure sealant on tooth surface

application of a 5% sodium fluoride varnish every 6 months

application of a 38% silver diamine fluoride solution onto tooth surface every year

application of water onto tooth surface every year

Outcomes

Primary Outcome Measures

dental caries
tooth decay appearing as a cavity on tooth surface

Secondary Outcome Measures

Full Information

First Posted
September 23, 2011
Last Updated
April 28, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01446107
Brief Title
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Official Title
A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
tooth decay, fluoride, sealant, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fissure sealant
Arm Type
Experimental
Arm Description
single placement of resin fissure sealant on tooth surface
Arm Title
fluoride varnish
Arm Type
Experimental
Arm Description
application of a 5% sodium fluoride varnish every 6 months
Arm Title
SDF solution
Arm Type
Experimental
Arm Description
application of a 38% silver diamine fluoride solution onto tooth surface every year
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
application of water onto tooth surface every year
Intervention Type
Other
Intervention Name(s)
placement of fissure sealant
Intervention Description
placement of resin-based fissure sealant at baseline without replacement
Intervention Type
Other
Intervention Name(s)
fluoride varnish
Intervention Description
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
Intervention Type
Other
Intervention Name(s)
silver fluoride
Intervention Description
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
Intervention Type
Other
Intervention Name(s)
placebo control
Intervention Description
application of water onto tooth surface every year
Primary Outcome Measure Information:
Title
dental caries
Description
tooth decay appearing as a cavity on tooth surface
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: school children in good general health have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries Exclusion Criteria: children with major systemic disease or taking long-term medications not cooperative or refuse dental treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward CM Lo, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22736448
Citation
Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
Results Reference
derived

Learn more about this trial

Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

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